Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers

Recruiting

• Conditions: Quality of Life; Larynx Cancer
• Interventions: Diagnostic Test: to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.

• Registration Number: NCT06086119
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Primary Completion: 2022-10-15
• Study First Submitted: 2023-03-29
• Status Verified: 2023-06
• Study First Submitted QC: 2023-10-10
• Last Update Submitted: 2023-10-10
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Study Completion: 2024-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
• Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
• Age > 18 years
• Written informed consent

Exclusion Criteria

• Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
• Patients who are unable to complete questionnaires/follow the rehabilitation pathway

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who will be subjected to total laryngectomy and placement of voice prosthesis	to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.	Prospective, multicenter observational study involving patients who will be subjected to total laryngectomy and placement of voice prosthesis.Evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis, through the administration of validated quality of life questionnaires: EORTC QLQ - H\&N35; EORTC QLQ -C30, V-RQOL, VHI, SECEL3,4

Primary Outcome Measures

Name	Time	Method
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis	Enlistment period: 2 years Total duration of the study: 36 months	Evaluate the perception of the voice of the patient undergoing surgery of voice prosthesis positioning, evaluating the optimal score (\>30) in terms of VHI.; To calculate the sample size we based our estimate on the percentage of patients not undergoing voice prosthesis with a VHI score greater than 30 (Good Score). Such percentage is approximately 35%, a figure reported in the literature. Assuming a difference of 25% in terms of percentage of patients undergoing voice prosthesis who have a VHI score greater than 30 (60%) to ensure a power (1-β) equal to 80% and an α error of 5%, it will be necessary to enlist a total of 31 patients with the required requirements. Descriptive statistics will be calculated for all variables of interest. The associations will come evaluated using Fisher's exact test. Differences between subgroups will be assessed using the Mann-Whitney U test. All statistical analyzes were conducted using SPSS statistical software (version 21.0)

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy